Director, Functional Process Expert
WHY JOIN US?
At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society.
Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you'll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people's lives.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
About the Opportunity:
Are you ready to lead and innovate in the world of clinical trials? As the Director, Study Management Functional Process Expert, you will be the pivotal link between Study Management and the Business Process Management Organisation (BPMO). Your role will be crucial in fostering a process-centric culture that enhances quality and efficiency across clinical processes. Collaborating closely with BPMO and Global Clinical Solutions, you will ensure that user requirements are met and effectively implemented in Study Management.
A core aspect of your role will be to translate high-level processes and SOPs into practical, actionable steps for global study teams—bridging the gap between written procedures and real-world operations. Leveraging your expertise in business process and stakeholder management, you will ensure clinical teams worldwide are both compliant and empowered to deliver with efficiency.
You will also support Business Process Area Leads in reviewing procedural documents and proactively manage upcoming process changes. Representing Study Management, you will address procedural framework governance, escalate issues, and coordinate evaluations of new procedures impacting Study Management.
Accountabilities:
Collaborate with BPMO and system owners to maintain global SM processes and tools.
Provide functional representation during process changes, offering leadership, process knowledge, and insights.
Translate SOPs and complex processes into reality for global study teams, enabling practical adoption and compliance across diverse teams.
Review and manage functional approval of changes to clinical business processes.
Develop and apply insights from process metrics to drive improvements.
Act as a change agent to support adoption of new processes and cultivate a continuous improvement mindset.
Serve as the first line of support for process users, addressing queries, troubleshooting issues, and facilitating effective knowledge transfer.
Proactively manage stakeholder relationships, collaborating to understand operational impact and enable successful process implementation.
Maintain industry best practice awareness and up-to-date knowledge of international standards.
Escalate unresolved issues or risks to BPMO.
Manage lifecycle of non-mandatory procedural documents and ensure compliance.
Champion process and SOPs at the functional level, supporting teams through training, guidance, and advocacy.
Communicate information effectively and develop high-quality training materials for a global audience.
Essential Skills and Experience:
Bachelor of Science in an appropriate discipline or equivalent experience.
At least 7 years of extensive operational experience in Drug Development within a pharmaceutical or clinical background.
High level of business process, technology, and Clinical Study information knowledge.
Demonstrated project management skills and proven ability to deliver to time and quality.
Substantial experience in process knowledge and stakeholder management—translating procedural frameworks into workable, real-world outcomes for global teams.
Experience working successfully and collaboratively with external partners.
Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management, and interpersonal skills.
Expert knowledge of Clinical Trials-related international regulations, guidelines, and standards (ICH GCP, FDA, EMA regulations and guidelines at minimum).
Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with a problem-solving focus.
Ability to drive and champion global change and actively advocate and implement more efficient and effective processes.
Ability to manage multiple competing priorities, demonstrating a growth mindset, innovation, ownership, and accountability.
Desirable for the Role:
Previous experience in Process Owner’s roles.
Previous experience in attending regulatory inspections.
Expert reputation within the business and industry.
Experience utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement.
Experience in the development and management of Business Process to deliver business performance.
AI literacy.
SO, WHAT’S NEXT?
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
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Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
#LI-Hybrid
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
